Mini-dose methotrexate combined with methylprednisolone for the initial treatment of acute GVHD: a multicentre, randomized trial

Table 1 Patient and transplant characteristics (intention-to-treat population)

Patient characteristics	MTX group (n = 78)	Control group (n = 79)
Gender
Male	42(54%)	42(53%)
Female	36(46%)	37(47%)
Median age, years, (range)	34(15–63)	34(15–62)
MAGIC criteria grade
I-II	74(95%)	71(90%)
III-IV	4(5%)	8(10%)
GVHD risk category
Standard	75(96%)	72(91%)
High	3(4%)	7(9%)
Underlying malignancy
Acute myeloid leukemia	32(41%)	41(52%)
Acute lymphoid leukemia	32(41%)	23(29%)
Myelodysplastic syndrome	11(14%)	12(15%)
Other malignant disease	3(4%)	3(4%)
Graft source
Peripheral blood	68(87%)	62(17%)
Bone marrow	10(13%)	17 (21%)
Donor source^a
Matched sibling donor	6(8%)	11(14%)
Matched unrelated donor	4(5%)	6(7%)
Haploidentical donor	68(87%)	62(79%)
GVHD prophylaxis^a
CsA + MMF + MTX	78(100%)	79(100%)
Baseline organ involvement
Specific organ involved
Skin	71(91%)	65(82%)
Lower gastrointestinal tract or liver	16(21%)	25(31%)
Single or multi organ involvement
Single	68(87%)	69(87%)
Multi	10(13%)	10(13%)

GVHD Graft-versus-host disease, HLA Human leukocyte antigen, MAGIC Mount Sinai Acute GVHD International Consortium, CsA Cyclosporine A, MMF Mycophenolate mofetil
^aThe conditioning regimen for haploidentical donor and matched unrelated donor HSCT included cytarabine (4 g/m²/day, day –9), busulfan (3.2 mg/kg/day, intravenously days –8 to –6), cyclophosphamide (1.8 g/m2/day, days –5 to –4), semustine (250 mg/m², day –3), and rabbit ATG (thymoglobulin; Imtix Sangstat, Lyon, France, 2.5 mg/kg/day, days –5 to –2). The conditioning regimen for matched sibling donor did not include ATG, otherwise identical to haploidentical donor and matched unrelated donor HSCT. Cyclosporine A (CsA), mycophenolate mofetil (MMF), and short-term MTX were given as GVHD prophylaxis. The dosage of methotrexate was 15 mg/m², administered i.v. on day + 1, followed by 10 mg/m² on days 3, 6, and 11 after haploidentical donor and matched unrelated donor HSCT( 10 mg/m² on days 3,6,after matched sibling HSCT)

ISSN: 1741-7015